MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-08-01 for SOFT CIRCUMCISION STRAP, INFANT 37500 manufactured by Kimberly-clark Corporation.
[16150945]
The incident device has not been received for investigation; however, the device history record was reviewed finding no anomalies to be documented. Further investigation of this product revealed the root cause of this failure mode to be related to the hook and loop seal. New functional tests have been implemented that require a minimum of 2 rows of sealant on each side of the hoop-and-loop and straps as well as applying pressure once the hook-and-loop have been connected to the strap. Information from this incident will be included in our product complaint & mdr trend reporting systems. Ongoing analysis of trend information is used to identify the need for additional investigations.
Patient Sequence No: 1, Text Type: N, H10
[16258717]
It has been reported to the manufacturer by a kc sales representative that during a circumcision procedure, the child's leg got free just as the physician was about perform the circumcision. There was no report of any patient injury. Kimberly-clark has no independent knowledge of the event reported, but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the kimberly-clark complaint database.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616096-2008-00002 |
| MDR Report Key | 1096272 |
| Report Source | 05,06 |
| Date Received | 2008-08-01 |
| Date of Report | 2008-07-31 |
| Date of Event | 2008-07-02 |
| Date Mfgr Received | 2008-07-02 |
| Device Manufacturer Date | 2007-12-19 |
| Date Added to Maude | 2008-10-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | COORDINATOR |
| Manufacturer Street | 1400 HOLCOMB BRIDGE ROAD, B200 |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer Phone | 7705877200 |
| Manufacturer G1 | KIMBERLY-CLARK CORPORATION |
| Manufacturer Street | KM 4.5 CARRETERA PRESA LA AMISTAD |
| Manufacturer City | CUIDAD DE ACUNA, COAHUIL 26200 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 26200 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFT CIRCUMCISION STRAP, INFANT |
| Generic Name | CIRCUMCISION STRAP |
| Product Code | GAX |
| Date Received | 2008-08-01 |
| Catalog Number | 37500 |
| Lot Number | AM7353874 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1231059 |
| Manufacturer | KIMBERLY-CLARK CORPORATION |
| Manufacturer Address | CUIDAD DE ACUNA, COAHUIL MX 26200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-01 |