MAUDE Adverse Event Report: LOHMANN & RAUSCHER GMBH & CO SUPRASORB X+PHMB; ANTIMICROBIAL WOUND DRESSING

Model Number 14X20CM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Death (1802); Multiple Organ Failure (3261); Multiple Organ Failure (3261)

Event Date 02/03/2020

Event Type  Death  

Manufacturer Narrative

Lohmann & rauscher (b)(4) as a foreign manufacturer is reporting an adverse event as identified in (b)(6) for suprsorb x+phmb as the manufacturer.While suprasorb x+phmb was never distributed within the usa it is a fda listed device for lohmann & rauscher (b)(4); however, a similar device was distributed as xcell¿ cellulose wound dressing antimicrobial, sterile 3.5 in.X 3.5 in.Under the lohman & rauscher brand and was distributed within the usa.This product was last sold in the usa on september 2018, with the last product distributed subsequently exceeding it's expiration date.Both suprasorb x+phmb and xcell antimicrobial products have been discontinued, and lohmann & rauscher will delist listing e616736 from fda database associated with product code mgq.Additionally, lohmann & rauscher's us subsidiary (b)(4) (importer) will also remove listing, d297355, for xcell and suprasorb x associated with product code mgq.Reference l&r usa inc.'s mdr (b)(4).

Event Description

Through this communication, on behalf of lohmann & rauscher we would like to inform you that on (b)(6) 2020, we received a report from dr.(b)(6) of the burned children unit of the state center for critical care in (b)(6), institute of public health of the state of (b)(6), referring to a (b)(6)-year-old male child who was admitted to the general hospital of (b)(6) due to a burn with hot water suffered on (b)(6) on the genital area and the lower extremities (approx.21% of the body area) and who was later transferred to the burned children unit of the state center for critical care of (b)(6), institute of public health of the state of (b)(6) on (b)(6).After the 3rd surgical debridement the child was treated with 5 pieces of our suprasorb x+phmb wound dressing (14x20cm, ref 20542, lot 1913311905) for 4-5 days without any change dressing (fixed as secondary dressing with an unelastic bandage.According to the medical report and the cofebris report sent by dr.(b)(6) to us the first symptoms were presented by the patient in the first 24 h up to severe liver failure and acute kidney failure and later died on (b)(6).The patient was co-treated with different medications such as paracetamol, dexmedetomidine, diphenhydramine, loratadine, cephalotin, amikacin, diphenhydramine, albendazole, among others, and additionally during treatment, the suprasorb x + phmb wound dressing was used.Lohmann & rauscher is currently conducting an evaluation of this case in order to determine the causal relationship (if there is any correlation between the event presented and the use of the suprasorb x + phmb wound dressing).Once the evaluation has been completed, we will submit a new notification to you with the results.

Manufacturer Narrative

Lohmann & rauscher (b)(4) as a foreign manufacturer is reporting an adverse event as identified in (b)(6) for suprsorb x+phmb as the manufacturer.While suprasorb x+phmb was never distributed within the usa a similar device was distributed as xcell¿ cellulose wound dressing antimicrobial, sterile 3.5 in.X 3.5 in.Under the lohman & rauscher brand and distributed within the usa by l&r usa inc.This product was last sold in the usa on (b)(6) 2018, with the last product distributed subsequently exceeding it's expiration date.Xcell products have been discontinued, and lohmann & rauscher will delist listing (b)(4) from fda database associated with product code mgq.Additionally, lohmann & rauscher's us subsidiary (b)(4) (importer) will also remove listing, (b)(4), for xcell associated with product code mgq.Reference l&r usa (b)(4) mdr (b)(4).Follow up report with information based upon fda request, ai letter (b)(4).Lohmann & rauscher (b)(4) formal response to requested information can be found in attachment 5.This response includes references to (b)(4), which is the reporting facility's event history analysis summary as (b)(4).

Event Description

Through this communication, on behalf of lohmann & rauscher we would like to inform you that on the (b)(6) 2020, we received a report from dr.(b)(6) of the burned (b)(6) unit of the state center for critical care in (b)(6), institute of public health of the state of (b)(6), referring to a (b)(6)-year-old male child who was admitted to the general hospital of (b)(6) due to a burn with hot water suffered on (b)(6) on the genital area and the lower extremities (approx.21% of the body area) and who was later transferred to the burned (b)(6) unit of the state center for critical care of (b)(6), institute of public health of the state of (b)(6) on (b)(6).After the 3rd surgical debridement the child was treated with 5 pieces of our suprasorb x+phmb wound dressing (14x20cm, ref 20542, lot 1913311905, description) for 4-5 days without any change dressing (fixed as secondary dressing with an unelastic bandage.According to the medical report and the cofebris report sent by dr.(b)(6) to us the first symptoms were presented by the patient in the first 24 hr up to severe liver failure and acute kidney failure and later died on (b)(6).The patient was co-treated with different medications such as paracetamol, dexmedetomidine, diphenhydramine, loratadine, cephalotin, amikacin, diphenhydramine, albendazole, among others, and additionally during treatment, the suprasorb x + phmb wound dressing was used.For more details please refer to the document attached which corresponds to the clinical history of the patient received by dr.(b)(6) (received (b)(6) 2020) as well as the report made by dr.(b)(6) to cofepris (received (b)(6) 2020).Lohmann & rauscher is currently conducting an evaluation of this case in order to determine the causal relationship (if there is any correlation between the event presented and the use of the suprasorb x + phmb wound dressing).Once the evaluation has been completed, we will submit a new notification to you with the results.

• Brand Name: SUPRASORB X+PHMB
• Type of Device: ANTIMICROBIAL WOUND DRESSING
• Manufacturer (Section D): LOHMANN & RAUSCHER GMBH & CO; irlicher strasse 55; neuwied, rhineland-palatinate 56579 ; GM 56579
• Manufacturer (Section G): LOHMANN & RAUSCHER GMBH & CO KG; irlicher strasse 55; neuwied, rheinland 56567 ; GM 56567
• Manufacturer Contact: scott moffatt ; 3880 w. wheelhouse rd; milwaukee, WI 53208 ; 4148925152
• MDR Report Key: 10219876
• MDR Text Key: 197206492
• Report Number: 9611462-2020-00001
• Device Sequence Number: 1
• Product Code: MGQ
• UDI-Device Identifier: 04021447924816
• UDI-Public: 4021447924816
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K024054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/05/2020

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 14X20CM
• Device Catalogue Number: 20542
• Device Lot Number: 1913311905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2020
• Initial Date FDA Received: 07/01/2020
• Supplement Dates Manufacturer Received: 06/05/2020
• Supplement Dates FDA Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Death
• Patient Age: 5 YR
• Patient Weight: 13