MAUDE Adverse Event Report: MUELLER SPORTS MEDICINE PF TAPE SYSTEM; TAPE SYSTEM FOR PLANTAR FASCIITIS 3A

Model Number 6327

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Tissue Damage (2104); Skin Tears (2516)

Event Date 02/13/2018

Event Type  Injury  

Manufacturer Narrative

Pf tape analysis, (b)(4).Purpose: the purpose of this testing was to analyze tape that had been returned as a part of complaint (b)(4) for the tape adhesive being too aggressive, with one application in the pack taking "the top layer of skin off his foot." samples: sample 1: "returned tape" - tape that was returned by the customer as part of complaint (b)(4) lot number 17221.Methods: 180 degree peel test (msm protocol (b)(4)) will be conducted to determine adhesive strength.Results: adhesive strength: the peel strength for the returned tape was 63 oz/in.The maximum peel strength on the specification is 160 oz/in (nominal 140 oz/in).Conclusion: the adhesive strength was much lower than the maximum allowable adhesive strength (in fact, it was lower than both nominal and specification minimum).This may be due to environmental factors (storage conditions, shipping conditions).Without lot test data, only the coa would be available for adhesive strength reference.There was also only one sample for testing, so it is impossible to rule out anomaly.There is no reason to believe that the product adhesive was unusually aggressive, so there is no clear explanation for the cause of skin injury.Without examination or knowledge of the skin condition of the user, it is impossible to rule out a pre-existing issue (such as broken skin, blistering, or skin irritation) which may have contributed to the injury.

Event Description

(b)(6) bough pftape from a (b)(6) store in (b)(6).The second application took the top layer of skin off his foot.He is now going to the doctor using his own insurance.He did state if he couldn't stand on his foot and go to work he was going to get a lawyer.He has the strip with the skin on it.Briefly spoke with consumer as he was in the emergency room.He will be calling me back when he can.This will be reportable to the fda under 21 cfr 803.I will ask customer service to refund and return tape for investigation.Spoke with customer this morning.Doctor visit resulted in a steroid and tetanus shot and cream treatment.

• Brand Name: PF TAPE SYSTEM
• Type of Device: TAPE SYSTEM FOR PLANTAR FASCIITIS 3A
• Manufacturer (Section D): MUELLER SPORTS MEDICINE; one quench drive; prairie du sac 53578
• Manufacturer (Section G): MUELLER SPORTS MEDICINE; one quench drive; prairie du sac WI 53578
• Manufacturer Contact: erin daly ; one quench drive; prairie du sac 53578 ; 6086438530
• MDR Report Key: 7588716
• MDR Text Key: 110672875
• Report Number: 2110420-2018-00002
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS I
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 02/13/2018
• Device Model Number: 6327
• Device Catalogue Number: 6327
• Device Lot Number: 17221
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 68